Company Description
NovaBone Products is a cutting-edge biotechnology company specializing in developing and manufacturing advanced biomaterials for bone regeneration. With a relentless commitment to improving patient outcomes and revolutionizing the field of synthetic biologics, NovaBone Products has emerged as a global leader in developing innovative bone graft substitutes.
Role Description
We are seeking a Regulatory Affairs Specialist to join our team. This candidate will be responsible for the execution of deliverables and outputs for the NovaBone Regulatory and Quality Management System. While working closely with Operations, R&D and other Quality personnel, this candidate will help to ensure that the company’s regulatory goals and initiatives are achieved. This candidate will additionally participate in the preparation and submission of technical documentation such that new global product registrations are achieved as planned around the world.
Responsibilities
- Participate in preparation of technical documentation for submission to national and international regulatory agencies
- Maintain expertise regarding existing and emerging regulations, standards, or guidance documents
- Communicate with Notified Bodies regarding various regulatory submissions and associated follow-up issues
- Assist with Quality System updates and routine documentation filing
- Assist in 510(k) submissions
- Assist in hosting audits from various regulators and customers pertaining to Regulatory Affairs issues
- Review and approve technical reports
Qualifications
- Bachelor's degree in scientific discipline preferred
- 2+ years of Regulatory Affairs experience within the medical device industry preferred
- Familiarity with the EU Medical Device Regulation
- Working knowledge of ISO 13485, 21 CFR 820
